Understanding the FDA’s Quality System Regulation, 21 CFR, Part 820



Compliance with 21 CFR, Part 820 (the FDA’s Quality System Regulation) is not optional for device manufacturers wanting to enter medical devices into commerce in the United States. Compliance is driven, in part, by device classification (three device classes in the U.S.). However, many device manufacturers entering products into commerce for the first time struggle to understand what is actually required for compliance.
If your organization is struggling with understanding the salient requirements associated with 21 CFR, Part 820, this webinar is for you. This webinar will help your organizations better understand the FDA’s expectations for implementing a Quality Management System (QMS), while providing insight into tools needed for establishing an effective approach to quality management. For establishments already having a compliant QMS, this webinar will help your organization streamline their approach to Quality Management.

Areas to be Covered:

Reviewing and understanding the requirements associated with 21 CFR, Part 820 compliance.
Regulatory and statutory requirements.
Similarities with ISO 13485:2003.
Device Classification.
Establishing QMS processes and procedures.
Documented evidence of compliance.
The importance of procedures and record collection.
Employing CAPA to drive QMS improvements.
The FDA’s inspection process.
Form 483 – inspectional observations.
The FDA Warning Letter process.

Who will Benefit:

A must attend webinar for all industry professionals, regardless of functional roles, will benefit from this training, especially if you are involved in the day-to-day activities associated with supporting your organization’s QMS. The staff who will benefit include:
Quality Professionals
Regulatory Professionals
Test Technicians
R & D Engineers
Manufacturing Engineers
Quality Engineers

Dr. Christopher J. Devine

Dr. Christopher Joseph Devine is the president and founder of Devine Guidance International, Inc., (DGII) a consulting firm providing regulatory and quality compliance support for the medical device industry. Prior to launching DGII, Dr. D spent 14-years with Boston Scientific Corporation working in a variety of quality and regulatory management roles. Additionally, Dr. Devine is the author of Devine Guidance, a weekly blog focusing on quality and regulatory compliance issues facing the medical device industry; and published by the Medical Device Summit, an e-magazine.

Furthermore, Dr. Devine has 35-years of combined experience in the fields of quality assurance and regulatory affairs; and is a senior member of the American Society of Quality (ASQ), a member of Regulatory Affairs Professionals Society (RAPS), a member of the Society of Manufacturing Engineers (SME), and a member of the Project Management Institute (PMI).

Dr. Devine received his doctorate from Northcentral University, with his doctoral dissertation entitled, “Exploring the Effectiveness of Defensive-Receiving Inspection for Medical Device Manufacturers: A Mixed-Method Study. Finally, Dr. Devine is the author of five books on quality and regulatory compliance.


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  • Recording access Information with Password to view the webinar, will be sent 24 hours after the completion of the Live webinar.
  • Presentation Handout in .pdf format
  • Certificate of Attendance